Summary

Eligibility
for people ages 40 years and up (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
completion around
Principal Investigator
by Igor Z Barjaktarevic, MD, PhD

Description

Summary

RARICO is a pragmatic, randomized, controlled, double-blinded, multi-center trial evaluating the safety and feasibility of nebulized revefenacin in comparison to nebulized ipratropium in patients with COPD and acute respiratory failure requiring invasive mechanical ventilation.

Official Title

Revefenacin in Acute Respiratory Insufficiency in COPD (RARICO)

Details

Objective: To assess the efficacy of nebulized revefenacin in improving the lung mechanics of COPD patients with acute respiratory failure requiring invasive mechanical ventilation (MV), in comparison to a control group receiving the short-acting muscarinic antagonist ipratropium.

Hypothesis: Revefenacin is as efficacious as ipratropium in improving the lung mechanics of COPD patients with acute respiratory failure.

Study Design:

RARICO is a pragmatic, randomized, controlled, double-blinded, multi-center trial evaluating the safety and feasibility of nebulized revefenacin in comparison to nebulized ipratropium in patients with COPD and acute respiratory failure requiring invasive mechanical ventilation.

Keywords

COPD, Acute Respiratory Failure, Long acting muscarinic antagonist, nebulizer, mechanical ventilation, Respiratory Insufficiency, Bromides, Ipratropium, Revefenacin Inhalation Solution [Yupelri], Ipratropium Bromide, Revefenacin

Eligibility

You can join if…

Open to people ages 40 years and up

  • Adults ≥ 40 years of age
  • Acute respiratory failure requiring invasive mechanical ventilation
  • Documented history of COPD based on spirometric evidence of FEV1/FVC<70%
  • Smoking history >10 years (current or prior)
  • Invasive mechanical ventilation for < 96 hours

You CAN'T join if...

  • Chronic invasive mechanical ventilation via tracheostomy. Patients with tracheostomy alone without chronic mechanical ventilation may be enrolled.
  • Expected duration of mechanical ventilation <24 hours
  • Hypersensitivity to muscarinic antagonists
  • Inability to tolerate albuterol
  • Lack of documented COPD history
  • For patients taking short- or long-acting muscarinic antagonists (SAMAs or LAMAs) at the time of screening, inability or unwillingness to undergo the SAMA or LAMA washout period (6 hours or 24 hours, respectively) prior to initiating study drug.
  • Presence of ARDS or acute congestive heart failure
  • Unwillingness or inability to remain on the study drug with for the duration of the study
  • Unwillingness or inability to have open-label muscarinic antagonists withheld for duration of the study
  • Unwillingness or inability to utilize the Puritan-Bennett 980 (PB980) ventilator
  • Pulmonary comorbidities such as pneumothorax or pneumomediastinum that, in the opinion of the investigator or clinical team, can pose a risk to subject safety or interfere with the subject's ability to complete the study procedures.
  • Documented restrictive lung disease or history of interstitial lung disease
  • Actual body weight exceeding 1 kg per centimeter of height
  • Pregnancy
  • AST or ALT > 3 times the upper limit of normal, or other clinically significant acute or chronic liver disease
  • Known history of glaucoma
  • Enrollment in other interventional clinical trial
  • Moribund patient not expected to survive >24 hours
  • Decision to withhold life-sustaining treatment, except in those patients committed to full support except cardiopulmonary resuscitation
  • Inability to obtain informed consent from patient or legally authorized representative (LAR)

Locations

  • Ronald Reagan Medical Center at UCLA accepting new patients
    Los Angeles California 90095 United States
  • Santa Monica UCLA accepting new patients
    Santa Monica California 90404 United States

Lead Scientist at UCLA

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Los Angeles
Links
Sign up for this study
ID
NCT04315558
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 21 study participants
Last Updated